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Opioid Withdrawal (Disorder)Phase 2TAPERNCT04070157

Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal

A Phase 2 study testing Lofexidine in people with Opioid Withdrawal (Disorder), run by USWM, LLC (dba US WorldMeds) at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Withdrawal (Disorder)
What is being tested?
Lofexidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
12 sitesUnited States
Study dates
2 Aug 2019to 27 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject can provide written informed consent.
  • Chronic non-cancer pain diagnosis such as low back pain, chronic neck pain, osteoarthritis, and prolonged post-surgical pain with daily pain for a minimum of 6 months.
  • Self-reported use of prescribed oral opioid medication(s) (tablets, pills or capsules) of at least 50 morphine mg equivalent (MME) but no higher than 240 mg MME daily or near daily (≥5 days per week) for at least 12 weeks and seeking to discontinue their opioid medication.
  • Willing to be treated with non-opioid treatments for pain (in addition to opioid being tapered) for duration of study.
  • Willing to abstain from alcohol use during the study.
  • Willing to partner with his or her pain physician on a subject-centered pain management plan during the study.
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  • In generally good health, in the opinion of the Investigator, other than the underlying chronic pain syndrome
  • Women of childbearing potential must have a negative pregnancy test at Screening.
  • Non-pregnant, non-lactating women who are postmenopausal, naturally or surgically sterile, or who agree to use acceptable contraceptive methods throughout the course of the study.
  • Other criteria will be discussed in detail with potential subjects by Site Investigator

Who cannot join

  • Has a primary diagnosis of complex regional pain syndrome, central neuropathic pain, somatoform pain syndromes, acute nerve root compression, any acute or progressive infectious, inflammatory, or neurological process.
  • Taking methadone, buprenorphine, fentanyl rapid acting products, tapentadol, tramadol, butorphanol, meperidine, or levorphanol for any reason
  • Liver disease that requires medication or medical treatment, and/or AST or ALT levels greater than 3 x ULN.
  • Gastrointestinal or renal disease, which would significantly impair absorption, metabolism or excretion of study drug, or would require medication or medical treatment.
  • Has a diagnosis of epilepsy or history of seizures.
  • Cardiovascular abnormalities at Screening and before randomization (stable hypertension permitted)
Show all 11Show fewer
  • Self-reported or evidence of opioid use disorder (OUD) or other substance use disorder within last 12 months
  • Any severe or unstable psychiatric disorder including post-traumatic stress disorder, schizophrenia, bipolar disorder, major depression, substance abuse, or suicidality as determined by the Investigator.
  • Subject answers "yes" to "suicidal ideation" in prior 24 months to any items 1 through 5 on the C-SSRS, or subject answers "yes" to any lifetime "suicidal behavior" item on the C-SSRS.
  • Any anticipated or scheduled surgery during the study period or within 30 days before Screening.
  • Other criteria will be discussed in detail with potential subjects by site Investigator

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Injury Care Research

    Boise, Idaho, 83713

  • Otrimed Corporation (Otrimed Clinical Research Center)

    Edgewood, Kentucky, 41017

  • Global Scientific Innovations

    Evansville, Indiana, 47714

  • Georgia Clinical Research, LLC

    Lawrenceville, Georgia, 30044

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66210

  • Westview Clinical Research, LLC

    Placentia, California, 92870

  • Gold Coast Research, LLC

    Plantation, Florida, 33317

  • Duke Innovation Pain Therapies Clinic at Brier Creek

    Raleigh, North Carolina, 27617

  • Vitamed Research

    Rancho Mirage, California, 92270

  • University of Rochester

    Rochester, New York, 14624

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • The Center for Clinical Research, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects With Chronic Non-Cancer Pain

Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.

Read the detailed description

This randomized, double-blind, placebo-controlled pilot study will evaluate the safety and effectiveness of LUCEMYRA in the treatment of opioid withdrawal during an opioid taper in subjects with chronic non-cancer pain.

Subjects will begin a planned 14-day complete taper of their pre-study opioid medications and will be randomly assigned (1:1) to either LUCEMYRA or matching placebo. Study drug will be administered through the opioid taper and for 5 days after the opioid taper is completed. Study drug will then be tapered over a 4-day period for a total of approximately 21 days exposure to study drug.

Being tested
Lofexidine, Placebo
Keywords
Opioid Withdrawal Syndrome, OWS, Opioid taper, Opioid withdrawal, Opioid reduction, Stopping opioids, Opioid discontinuation, non-opioid pain management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LofexidineDrug

    Also called lofexidine hydrochloride, LUCEMYRA

    Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.

  • PlaceboDrug

    Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.

Study groups in NCT04070157
Study groupRoleWhat they receive
LofexidineExperimentalNot described
Receives: Drug: Lofexidine
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Treatment Emergent AEs and SAEs

    Measured: Day 1 through Day 28

  2. Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation

    Measured: Day 1 through Day 28

  3. Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests

    Measured: Day 1 through Day 28

  4. Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale

    The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a "yes" in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds "yes" to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral.

    Measured: Day 1 through Day 28

  5. Change in Blood Pressure

    Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.

    Measured: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28

  6. Change in Pulse

    Measured: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28

Secondary outcomes (18)

  1. Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation

    Measured: Day 1 through Day 28

  2. Change in Clinical Opiate Withdrawal Scale (COWS)

    The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48.

    Measured: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28

  3. Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)

    The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome.

    Measured: Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28

  4. Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)

    The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome.

    Measured: Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28

  5. Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score

    MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug.

    SEVERITY OF ILLNESS:

    1. = No at all ill
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = Among the most extremely ill subjects

    SIDE EFFECTS INDEX:

    1. = None, study drug is producing no side effects
    2. = Do not significantly interfere with subject's functioning
    3. = Significantly interferes with subject's functioning
    4. = Outweighs therapeutic effect

    Measured: Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)

  6. Modified Clinical Global Impression - Subject Version (MCGI-S)

    Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug.

    SEVERITY OF OPIATE WITHDRAWAL:

    1. = No opiate withdrawal symptoms
    2. = On the border between no to mild opiate withdrawal symptoms
    3. = Mild opiate withdrawal symptoms
    4. = Moderate opiate withdrawal symptoms
    5. = Marked opiate withdrawal symptoms
    6. = Severe opiate withdrawal symptoms
    7. = The most severe opiate withdrawal symptoms that I have ever had

    SIDE EFFECTS INDEX (Scale B):

    1. = None. The study drug has no side effects
    2. = The study drug has slight side effects, but it does NOT significantly interfere with my day to day activities
    3. = The study drug has moderate side effects, and it DOES significantly interfere with my day to day activities
    4. = The study drug has severe side effects, and these side effects are greater than the relief from opiate withdrawal symptoms that it provides

    Measured: Each scheduled evaluation (Day 1 through Day 28)

  7. Time to Study Drug Discontinuation

    Study day of participant discontinuation.

    Measured: Day 1 through Day 28

  8. Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day

    Measured: Day 1 through Day 28

  9. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale

    The EQ-5D-5L is an instrument that evaluates preference for health status through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of which are rated on 5 levels of severity. Each dimension ranges from a minimum of "0 - I have no problems or I am not" to a maximum of "5 - I am unable to or I am extremely". The dimensions are averaged together for a single score and the change in average score from baseline is recorded.

    Measured: Change from Baseline to EOS

  10. Change in Short Form Health Survey (SF-36) Scale

    The SF-36 consists of 36 questions that measure various aspects of physical and mental well-being. Precoded values are recorded for each question ranging from 0-100, with a high score defined as a more favorable health status. The items are then averaged together to create the 8 scale scores which are averaged together to create a scale.

    The final value reported is the average change in the averaged scale scores from baseline to end of study.

    Measured: Change from baseline to End of Study, up to 55 days

  11. Change in Insomnia Severity Index (ISI)

    The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item on a scale 0 to 4 for each of the 7 items, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

    Measured: Change from baseline to Days 15 and End of Study, up to 55 days

  12. Change in Hospital Anxiety and Depression Scale (HADS)

    The HADS is a self-reported screening tool for anxiety and depression in nonpsychiatric clinical populations. Responses are based on the relative frequency of symptoms over the preceding week. The scale consists of 14 items, with a subscale of 7 questions for anxiety and 7 questions for depression. Patients rate each item in the subscales on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Possible scores range from 0 to 21 for each subscale. An analysis of scores on the 2 subscales supported the differentiation of each mood state into 4 ranges: non-cases (scores 0 to 7), mild cases (scores 8 to 10), moderate cases (scores 11 to 15), and severe cases (scores 16 or higher), with lower values being favorable. The subscales are then combined for a total score ranging from 0 to 42. Higher scores indicate greater levels of anxiety or depression. The value reported is the average change from baseline to End of Study.

    Measured: Change from End of Study to Baseline, up to 55 days

  13. Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)

    A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain.

    The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.

    Measured: Baseline through Follow-up (assessed daily)

  14. Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)

    The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.

    Measured: Day 1 through Day 28 (assessed daily)

  15. Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)

    The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.

    Measured: Baseline through Day 51 (assessed daily)

  16. Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)

    The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.

    Measured: Day 1 through Day 28 (assessed daily)

  17. Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)

    Measured: Baseline through Day 28

  18. Change in Daily Opioid Dose as a Percentage of the Baseline MED

    Measured: Baseline through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start2 Aug 2019
  3. Primary completion27 Nov 2019
  4. Study completion27 Nov 2019

Why it stopped: COVID pandemic and enrollment issues necessitating an adjustment to the study design.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070157
Sponsor's protocol ID
USWM-LX1-2010
Acronym
TAPER
Status last verified
Oct 2024
First submitted
2 Jul 2019
Last updated
21 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lofexidine in people with Opioid Withdrawal (Disorder), run by USWM, LLC (dba US WorldMeds) at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent AEs and SAEs (time frame: Day 1 through Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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